Improving Evidence-Based Care for Cancer Patients

Sponsor
Medical University of South Carolina (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03207594
Collaborator
National Institutes of Health (NIH) (NIH)
128
1
78.9
1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to improve cancer care and the delivery of cancer care. Researchers are interested in studying patient reported information and examining how different factors may impact cancer care.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey
  • Other: Saliva sample
  • Other: Smoking Status questions

Study Design

Study Type:
Observational
Actual Enrollment :
128 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Improving Evidence-Based Care for Cancer Patients
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Arm 1

Current smokers with cancer who are planning to get radiation therapy at MUSC.

Other: Survey
Subjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life.

Other: Saliva sample
Subjects will have saliva collected by a member of the study team using a cotton swab.

Other: Smoking Status questions
Subjects will be asked to complete an assessment asking questions about his/her current smoking status

Outcome Measures

Primary Outcome Measures

  1. Number of patients with biochemically confirmed smoking cessation [4 weeks after enrollment]

    Biochemical confirmation will be determined by saliva samples

  2. Number of patient who self-report smoking cessation [4 weeks after enrollment]

    Self-reported smoking cessation will be documented via smoking assessment questionnaire

Secondary Outcome Measures

  1. Average weekly smoke exposure [up to 62 weeks]

    reported cigarettes per day multiplied by the number of days smoked during radiation therapy (RT), summed over a period of time and normalized to yield an average weekly smoke exposure during RT.

  2. Number of patients who participate in smoking cessation [up to 12 months after completion of RT.]

    Completing one in-person visit where an individualized smoking cessation treatment plan is developed and implemented.

  3. Compliance with smoking cessation [up to 12 weeks after completion of RT]

    Two binary measure of compliance: - completing at least three in person visits within 6 weeks of starting an individualized cessation treatment plan - completing at least one in-person visit and at least two phone-based communications

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancer

  • 21 years of age or older at time of study registration

  • Must have been referred to MUSC radiation oncology for treatment with curative radiation therapy

  • Must report current smoking defined as self-reporting smoking within the past 30 days using a structured intake questionnaire.

Exclusion Criteria:
  • Patients with primary central nervous system malignancies will be excluded.

  • Patients that have other cancer disease types will be excluded due to either significant differences in standard radiation therapy approaches or rarity of disease required radiation.

  • Patients who are currently participating in the Medical University of South Carolina Hollings Cancer Center smoking cessation program

  • Patients who are unable to provide informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Graham Warren, MD, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT03207594
Other Study ID Numbers:
  • 102472
First Posted:
Jul 5, 2017
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022